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Review
. 2012 Jun;61(6):1323-30.
doi: 10.2337/db11-1452.

Through the fog: recent clinical trials to preserve β-cell function in type 1 diabetes

Carla J Greenbaum  1 , Desmond A Schatz, Michael J Haller, Srinath Sanda
Affiliations
Review

Through the fog: recent clinical trials to preserve β-cell function in type 1 diabetes

Carla J Greenbaum et al. Diabetes. 2012 Jun.
No abstract available

PubMed Disclaimer

Figures

FIG. 1.
FIG. 1.
Effects of therapy to preserve β-cell function appear early. Solid black box is shown in each panel to emphasize time period of therapeutic effect. A: Circles represent the placebo group, and triangles represent the ChAglyCD3 group. Dashed lines show the glucose clamp–induced C-peptide release before glucagon injection and solid lines show after glucagon injection. Reprinted with permission; copyright Massachusetts Medical Society, 2005 (17). B: Area under the curve (AUC) C-peptide from 2-h mixed-meal tolerance test in placebo (solid line) and rituximab-treated (dashed line) subjects. The 95% confidence limits are shown at each time point within each group. Reprinted with permission; copyright Massachusetts Medical Society, 2009 (29). C: Population mean of stimulated C-peptide 2-h AUC mean over time for each treatment group (placebo, red; abatacept, blue). The estimates are from the ANCOVA model adjusting for age, sex, baseline value of C-peptide, and treatment assignment. Error bars show 95% CIs. Reprinted with permission from The Lancet (30).
FIG. 2.
FIG. 2.
Deciding which therapies to bring to phase 2 clinical trial. To enhance confidence that a phase 2 clinical trial will prove efficacious, we must guard against evidential conservatism which is the tendency to base clinical inferences on narrow classes of evidence (47). Decisions about which therapy to bring to clinical trial have often been made by evaluation of results in a single animal model, another autoimmune disease, or by data collected with the aim to demonstrate the expected effect. In other words, in our enthusiasm to bring new discoveries to trial, we heavily weigh evidence that supports the new ideas. Before launching a full-scale clinical trial, dispassionate and systemic collection and review of the totality of data including in vitro studies with human samples and in vivo proof of mechanism clinical studies are needed.
See this image and copyright information in PMC

Comment in

References

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